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Title: | Developing consensus-based priority outcome domains for trials in kidney transplantation: A multinational Delphi survey with patients, caregivers and health professionals. [Transplantation] | Authors: | Shen J.I.;Marson L.;Josephson M.A.;Reese P.P.;Pruett T.L.;Hanson C.S.;O'Donoghue D.;Tam-Tham H.;Halimi J.-M.;Kanellis J.;Craig J.C.;Rajan T.;Chadban S.;McDonald S.P.;Mandayam S.;Knight S.;Jesudason S.;Fung S.;Oberbauer R.;Masson P.;Evangelidis N.;Cross N.;Howell M.;Howard K.;Scandling J.D.;Sautenet B.;Tong A.;Manera K.E.;Chapman J.R.;Warrens A.N.;Rosenbloom D.;Wong G.;Gill J.;Budde K.;Rostaing L. | Monash Health Department(s): | Nephrology | Institution: | (Sautenet, Tong, Manera, Wong, Hanson, Howard, Howell, Evangelidis, Craig) Sydney School of Public Health, University of Sydney, Sydney, NSW 2145, Australia (Sautenet, Tong, Manera, Wong, Hanson, Howell, Evangelidis, Craig) Centre for Kidney Research, Children's Hospital at Westmead, Westmead, Sydney, Australia (Sautenet, Halimi) Faculte de Medecine, Universite Francois Rabelais, Tours, France (Sautenet, Halimi) Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France (Sautenet) INSERM, Tours U1246, France (Chapman, Wong) Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia (Warrens) School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (Rosenbloom) ESRD Network 18, Los Angeles, CA, United States (Gill) Division of Nephrology, University of British Columbia, Vancouver, Canada (Budde) Department of Nephrology Charite, Universitatsmedizin, Berlin, Germany (Rostaing) Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire, Rangueil, Toulouse, France (Marson) University of Edinburgh, Edinburgh, United Kingdom (Josephson) Department of Medicine, University of Chicago, Chicago, IL, United States (Reese) Renal Division, University of Pennsylvania Perelman, School of Medicine, Philadelphia, PA, United States (Pruett) Department of Surgery, University of Minnesota, Minneapolis, MN, United States (O'Donoghue) Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom (Tam-Tham, Rajan) Department Community Health Sciences, University of Calgary, Calgary, Canada (Shen) Department of Nephrology, Los Angeles Biomedical Research Institute, UCLA Medical Center, Los Angeles, CA, United States (Kanellis) Department of Nephrology, Monash Health and Centre for Inflammatory Diseases, Department of Medicine, Monash University, Clayton, VIC, Australia (Scandling) Department of Medicine, Stanford University, School of Medicine, Stanford, CA, United States (Cross) Department of Nephrology, Christchurch Hospital, Christchurch, New Zealand (Masson) Department of Renal Medicine, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom (Oberbauer) Department of Internal Medicine, Division of Nephrology, University of Vienna, Vienna, Austria (Fung) Jockey Club Nephrology and Urology Centre, Princess Margaret Hospital, Hong Kong (Jesudason, McDonald) Central and Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, SA, Australia (Jesudason, McDonald) Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia (Knight) Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom (Mandayam) Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX, United States (McDonald) ANZDATA Registry, South Australia Health and Medical Research Institute, Adelaide, Australia (Chadban) Renal Medicine and Transplantation, Royal Prince Alfred Hospital, Sydney, Australia | Issue Date: | 16-Aug-2017 | Copyright year: | 2017 | Publisher: | Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org) | Place of publication: | United States | Publication information: | Transplantation. 101 (8) (pp 1875-1886), 2017. Date of Publication: 01 Aug 2017. | Journal: | Transplantation | Abstract: | Background Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. Methods In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. Results One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, >=7.5; median, >=8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): Skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: Capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Conclusions Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.Copyright © 2017 Wolters Kluwer Health, Inc. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1097/TP.0000000000001776 | Link to associated publication: | Click here for full text options | PubMed URL: | 28738403 [http://www.ncbi.nlm.nih.gov/pubmed/?term=28738403] | ISSN: | 0041-1337 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/39413 | Type: | Article | Subjects: | major clinical study male malignant neoplasm middle aged mortality *patient care cognition *caregiver *kidney transplantation Likert scale human *health practitioner female depression Delphi study controlled study consensus comorbidity chronic graft rejection *practice guideline cardiovascular disease blood pressure article aged adult priority journal young adult acute graft rejection infection priority journal acute graft rejection adult aged Article blood pressure cardiovascular disease chronic graft rejection cognition comorbidity consensus controlled study Delphi study depression female *health practitioner human infection *kidney transplantation Likert scale major clinical study male malignant neoplasm middle aged mortality *patient care *practice guideline young adult *caregiver |
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